Senior Director, Global Regulatory Affairs

Role Overview & Key Functions:

The Global Regulatory & CMC Lead is responsible for the development and implementation of regulatory strategies for specific projects, while serving as the regulatory representative on the respective program teams. This includes Karyopharm's key clinical programs, international submissions in collaboration with our multiple alliance partners, and all CMC initiatives and submissions.

Reporting to our Senior Vice President, Regulatory Affairs, you will positively impact patients' lives with the following contributions:

• Accountable for the assigned regulatory portfolio from strategy development and implementation to execution of submissions for all stages of development
• Oversee clinical trial submissions and regulatory strategies globally
• Provide regulatory leadership and guidance to assigned program teams and CMC project teams
• Responsible for regulatory compliance with pre- and post-approval filings and reporting requirements
• Develop response and submission strategies to regulatory information requests in close collaboration with cross-functional team members and alliance partners, as applicable
• Develop various briefing packages and regulatory applications to the FDA and other global health authorities, as applicable, including CMC projects

• Lead as Regulatory CMC in all Change Control assessments and implementation of global roll-out including all external partners
• Support Regulatory inspections, as needed

• Contribute to regulatory intelligence, regulatory science, and regulatory policy
• Work collaboratively within Regulatory Affairs and cross-functional teams
• Prepare and deliver effective presentations for external and internal audiences
• Contact regulatory agencies relevant to assigned projects or programs, as appropriate
• Participate and contribute to Health Authority meetings

Candidate Profile & Requirements:

• Minimum B.S. degree in life/health/technical sciences required
• Postgraduate degree in Regulatory Affairs a plus
• Previous oncology experience highly preferred
• Minimum 10+ years of regulatory experience within the biotech or pharmaceutical industry
• A minimum of 7 years regulatory experience within the drug development and approval process in IND/CTAs/Marketing Applications; and a minimum of at least 5 years of Regulatory CMC hands-on experience

Our Value Proposition:

At Karyopharm, we live and demonstrate our ICARE values every day!

If you want to do something that matters, this work matters. Patients drive our passion to pioneer novel cancer therapies. That's why we've built an environment centered around support, flexibility, and a shared mission.

Creating and delivering medicine for cancer can only be done through focus, dedication, and heart. We hire exceptional people and trust each other to work in whatever way lets us, be us - whether that's onsite, from home, or anywhere in between.

What do you get when you pair an extraordinary mission with a culture of flexibility and empowerment? We invite you to find out and join us on this incredible mission.

Check out our Culture Video!

What We Offer:

In addition to our exciting, supportive, and intellectually challenging global workspaces(s), teamembers enjoy a comprehensive and generous benefits package (active on day one) that makes them more productive and contributes directly to the development of their professional skills.

• A culture of employee engagement, diversity, and inclusion
• Competitive salary, bonus, and generous equity offerings (RSU's at time of offer and annual awards) - we are partners in prosperity!
• Peace of mind through best in class medical (deducible paid by KPTI), dental, vision, disability, and life insurance, parental leave, a matching 401k program (immediate vesting), ESPP and tuition reimbursement.
• Wellness Program with a monthly stipend.
• Generous PTO and Holidays - we encourage you to recharge and spend time with family and friends.
• Ample opportunities to learn and take on new responsibilities in a fast-paced, and patient focused company. (tuition reimbursement, management development & mentoring programs, and a variety of reward and recognition programs)
• In the U.S., the salary range for this position is $230,000 to $255,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors
• Cell phone allowance